U.S. patent application number 16/300602 was filed with the patent office on 2019-07-11 for balloon catheter.
This patent application is currently assigned to Cryotherapeutics GmbH. The applicant listed for this patent is CRYOTHERAPEAUTICS GMBH. Invention is credited to Stewart Maddison FOX, Peter Georg LAITENBERGER, Peter Kyone PARK, Dominic SANTOIANNI.
Application Number | 20190209368 16/300602 |
Document ID | / |
Family ID | 58701619 |
Filed Date | 2019-07-11 |
United States Patent
Application |
20190209368 |
Kind Code |
A1 |
PARK; Peter Kyone ; et
al. |
July 11, 2019 |
Balloon Catheter
Abstract
A catheter is provided comprising a flexible heat transfer
element provided on an outer surface of the catheter, a conduit
arranged to supply an inflation fluid for inflating the flexible
heat transfer element so as to form an inflated balloon, a guide
wire lumen for receiving a guide wire, and an elongate cooling
element arranged to cool said inflation fluid for inflating the
balloon. Said cooling element and said guide wire lumen are
arranged inside the flexible heat transfer element such that, when
inflated the cooling element is substantially central within the
balloon and said guide wire lumen is parallel to and radially
offset from the cooling element.
Inventors: |
PARK; Peter Kyone;
(Milpitas, CA) ; SANTOIANNI; Dominic; (Kirkland,
CA) ; FOX; Stewart Maddison; (Cambridge, GB) ;
LAITENBERGER; Peter Georg; (Cambridge, GB) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
CRYOTHERAPEAUTICS GMBH |
Cologne |
|
DE |
|
|
Assignee: |
Cryotherapeutics GmbH
Cologne
DE
|
Family ID: |
58701619 |
Appl. No.: |
16/300602 |
Filed: |
May 9, 2017 |
PCT Filed: |
May 9, 2017 |
PCT NO: |
PCT/EP2017/061090 |
371 Date: |
November 12, 2018 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
62335885 |
May 13, 2016 |
|
|
|
Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61F 2007/0058 20130101;
A61B 2018/00023 20130101; A61B 2018/0212 20130101; A61B 18/02
20130101; A61M 2025/1088 20130101; A61F 2007/126 20130101; A61B
2018/00011 20130101; A61B 2018/00577 20130101; A61B 2018/00041
20130101; A61F 7/0085 20130101; A61B 2018/0268 20130101; A61M
25/1002 20130101; A61B 2018/0022 20130101; A61F 7/123 20130101;
A61F 2007/0092 20130101 |
International
Class: |
A61F 7/12 20060101
A61F007/12; A61F 7/00 20060101 A61F007/00 |
Claims
1. A catheter comprising: a flexible heat transfer element provided
on an outer surface of the catheter; a conduit arranged to supply
an inflation fluid for inflating the flexible heat transfer element
so as to form an inflated balloon; a guide wire lumen for receiving
a guide wire; and an elongate cooling element arranged to cool said
inflation fluid for inflating the balloon; wherein said cooling
element and said guide wire lumen are arranged inside the flexible
heat transfer element such that, when inflated the cooling element
is substantially central within the balloon and said guide wire
lumen is parallel to and radially offset from the cooling element;
and wherein the flexible heat transfer member is configured to
inflate anisotropically when viewed in the plane normal to the
longitudinal axis of the cooling element so as to form the
balloon.
2. The catheter according to claim 1, wherein said cooling element
is arranged within the balloon so that, in use, the inner surface
of the balloon is cooled substantially uniformly by the cooling
element around the circumference of the balloon.
3. The catheter according to claim 1, wherein the elongate cooling
element extends along a longitudinal axis in a direction parallel
to a central axis of the balloon.
4. The catheter according to claim 3, wherein the central axis of
the balloon is radially offset from the longitudinal axis of the
elongate cooling element by 0.1 to 0.5 mm, more preferably 0.2 to
0.4 mm.
5. The catheter according to claim 1, wherein the cooling element
is arranged inside the flexible heat transfer element such that,
when viewed in the plane normal to the longitudinal axis of the
cooling element, the cooling ele-element is provided substantially
within the centre of the balloon.
6. (canceled)
7. The catheter according to claim 1, wherein the flexible heat
transfer element is configured to inflate into a substantially
cylindrical balloon having first and second asymmetric ends.
8. The catheter according to claim 1, wherein the conduit arranged
to supply an inflation fluid, the guide wire lumen and the elongate
cooling element are provided inside a shaft, wherein the flexible
heat transfer element is adhered to the shaft at the first end, and
wherein the flexible heat transfer element is adhered to the guide
wire lumen at the second end.
9. The catheter according to claim 1, wherein said cooling element
comprises a first tube provided inside a second tube, wherein the
first tube is substantially parallel to the second tube; and the
second tube is configured to receive a flow of a coolant for
cooling the cooling element from the first tube.
10. The catheter according to claim 1, wherein, in use, the first
tube and the second tube are operated such that the pressure of the
second tube is lower than the first tube.
11. The catheter according to claim 1, wherein said cooling element
comprises an elongate cooling chamber configured to receive coolant
from the first tube and provide said coolant to the second
tube.
12. The catheter according to claim 10, wherein the elongate
cooling chamber is arranged co-linearly with an end of the second
tube, wherein said cooling element further comprises a restriction
tube configured to convey the coolant from the first tube to the
cooling chamber, wherein said restriction tube has narrower
internal diameter than the first tube, and wherein the restriction
tube and cooling chamber are configured such that when the coolant
conveyed along the first tube as a liquid, at least some of the
coolant undergoes a phase change in the restriction tube and/or in
the cooling chamber and returns through the second tube as a
gas.
13. (canceled)
14. (canceled)
15. The catheter according to claim 1, wherein, said balloon is
substantially cylindrical.
16. The catheter according to claim 1 wherein, in use in a vessel,
the inflated flexible heat transfer element occludes fluid flow
between the walls of the vessel and the inflated flexible heat
transfer element.
17. The catheter according to claim 1, wherein the conduit is
further configured to provide a return flow of the inflation fluid
of the flexible heat transfer element.
18. The catheter according to claim 1, wherein the central axis of
the balloon extends through the elongate cooling element, in the
direction of the longitudinal axis of the cooling element.
19. The catheter according to claim 1, wherein said cooling element
is not attached to the end of the guide wire lumen and wherein said
cooling element is configured such that, when in use, the flow of
the coolant causes the cooling element to vibrate.
20. The catheter according to claim 1, wherein the flexible heat
transfer element has single walled outer membrane.
21. The catheter according to claim 1, further comprising a heater
for heating the inflation fluid, or solidified inflation fluid, of
the flexible heat transfer element.
22. The catheter according to claim 1, wherein the conduit, the
guide wire lumen and the cooling element protrude from a shaft, and
wherein, inside the shaft, the cooling element has an outer surface
having a flattened-circular shape when viewed in the plane normal
to the longitudinal axis of the cooling element.
23. The catheter according to claim 1, wherein the conduit, the
guide wire lumen and the cooling element protrude from a shaft, the
shaft comprising a solid body occupying the regions between the
conduit, the guide wire lumen and the cooling element.
Description
FIELD
[0001] The present invention relates to balloon catheters for the
invasive treatment of a body. The catheter comprises an elongate
cooling element arranged centrally within a balloon to provide even
cooling across the surface of the balloon.
BACKGROUND
[0002] From the late 1970s, catheters for cryotherapy have been
used in the cardiovascular system starting from, for example, 1977
when it was used to surgically treat cardiac arrhythmias. Over the
ensuing years it became widely recognised that cryotherapy was
particularly advantageous for working in the heart. Its safety and
efficacy was unsurpassed as surgeons were able to ablate delicate
cardiac structures such as the A-V node, pulmonary veins and
delicate peri-nodal atrial tissue without concern for thrombosis,
perforation or other adverse events.
[0003] A catheter for the treatment of plaque stabilisation by
cryotherapy is described in WO 2015/067414 (referred to hereinafter
as WO'414). A balloon is inflated around a catheter shaft and
subsequently cooled. A co-axially arranged cooling element is used
to achieve this, wherein a liquid coolant is conveyed from an inner
supply lumen into a larger conduit. When exiting the supply lumen
the coolant undergoes a phase change due to the pressure drop which
occurs, causing it to evaporate and reduce in temperature. The cold
gas is then removed using a return lumen which surrounds the supply
lumen in a co-axial manner.
[0004] A number of advantages are provided by the above co-axial
design, as discussed in WO'414. For example, a single layered
balloon may be used since there is little risk of a gas coolant
leaking from the catheter. Furthermore cooling occurs, via the
phase change, in the location where it is required without the need
for insulating layers to be provided. Further still, the cooling
element and its supporting lumen may maintain a small cross
sectional area, making it suitable for applications in small
diameter arteries, for example for the treatment of coronary
vascular diseases. There remains a need however to improve known
designs of catheters for cryotherapy.
SUMMARY OF THE INVENTION
[0005] According to an aspect of the invention, there is provided a
catheter comprising: a flexible heat transfer element provided on
an outer surface of the catheter; a conduit arranged to supply an
inflation fluid for inflating the flexible heat transfer element so
as to form an inflated balloon; a guide wire lumen for receiving a
guide wire; and an elongate cooling element arranged to cool said
inflation fluid for inflating the balloon; wherein said cooling
element and said guide wire lumen are arranged inside the flexible
heat transfer element such that, when inflated the cooling element
is substantially central within the balloon and said guide wire
lumen is parallel to and radially offset from the cooling
element.
[0006] Preferably, said cooling element is arranged within the
balloon so that, in use, the inner surface of the balloon is cooled
substantially uniformly by the cooling element around the
circumference of the balloon.
[0007] Preferably, the elongate cooling element extends along a
longitudinal axis in a direction parallel to a central axis of the
balloon.
[0008] Preferably, the central axis of the balloon is radially
offset from the longitudinal axis of the elongate cooling element
by 0.1 to 0.5 mm, more preferably 0.2 to 0.4 mm.
[0009] Preferably, the cooling element is arranged inside the
flexible heat transfer element such that, when viewed in the plane
normal to the longitudinal axis of the cooling element, the cooling
element is provided substantially within the centre of the
balloon.
[0010] Preferably, the flexible heat transfer member is configured
to inflate anisotropically when viewed in the plane normal to the
longitudinal axis of the cooling element so as to form the
balloon.
[0011] Preferably, the flexible heat transfer element is configured
to inflate into a substantially cylindrical balloon having first
and second asymmetric ends.
[0012] Preferably, the conduit arranged to supply an inflation
fluid, the guide wire lumen and the elongate cooling element are
provided inside a shaft, wherein the flexible heat transfer element
is adhered to the shaft at the first end, and wherein the flexible
heat transfer element is adhered to the guide wire lumen at the
second end.
[0013] Preferably, said cooling element comprises a first tube
provided inside a second tube, wherein the first tube is
substantially parallel to the second tube; and the second tube is
configured to receive a flow of a coolant for cooling the cooling
element from the first tube.
[0014] Preferably, in use, the first tube and the second tube are
operated such that the pressure of the second tube is lower than
the first tube.
[0015] Preferably, said cooling element comprises an elongate
cooling chamber configured to receive coolant from the first tube
and provide said coolant to the second tube.
[0016] Preferably, the elongate cooling chamber is arranged
co-linearly with an end of the second tube.
[0017] Preferably, said cooling element further comprises a
restriction tube configured to convey the coolant from the first
tube to the cooling chamber, wherein said restriction tube has
narrower internal diameter than the first tube.
[0018] Preferably, the restriction tube and cooling chamber are
configured such that when the coolant conveyed along the first tube
as a liquid, at least some of the coolant undergoes a phase change
in the restriction tube and/or in the cooling chamber and returns
through the second tube as a gas.
[0019] Preferably, said balloon is substantially cylindrical.
[0020] Preferably, in use in a vessel, the inflated flexible heat
transfer element occludes fluid flow between the walls of the
vessel and the inflated flexible heat transfer element.
[0021] Preferably, the conduit is further configured to provide a
return flow of the inflation fluid of the flexible heat transfer
element.
[0022] Preferably, the conduit comprises: a third tube for
providing a supply flow of the inflation fluid of the flexible heat
transfer element; and a fourth tube for providing a return flow of
the inflation fluid of the flexible heat transfer element.
[0023] Preferably, said cooling element is not attached to the end
of the guide wire lumen and wherein said cooling element is
configured such that, when in use, the flow of the coolant causes
the cooling element to vibrate.
[0024] Preferably, the flexible heat transfer element has single
walled outer membrane.
[0025] Preferably the catheter further comprises a heater for
heating the inflation fluid, or solidified inflation fluid, of the
flexible heat transfer element.
[0026] Preferably, the conduit, the guide wire lumen and the
cooling element protrude from a shaft, wherein, inside the shaft,
the cooling element has an outer surface having a
flattened-circular shape when viewed in the plane normal to the
longitudinal axis of the cooling element.
[0027] Preferably the conduit, the guide wire lumen and the cooling
element protrude from a shaft, the shaft comprising a solid body
occupying the regions between the conduit, the guide wire lumen and
the cooling element.
LIST OF FIGURES
[0028] Embodiments of the invention will now be discussed with
reference to the accompanying drawings in which:
[0029] FIG. 1 is a schematic illustration of a cross section of a
cooling element of a catheter according to an embodiment;
[0030] FIG. 2 is a schematic illustration of a cooling element of a
catheter according to an embodiment;
[0031] FIG. 3 is a schematic illustration of a cross section of a
cooling element of a catheter according to an embodiment;
[0032] FIG. 4 is a schematic illustration of the distal end of a
catheter according to an embodiment;
[0033] FIG. 5 is a schematic illustration of a cross section of the
distal end of a catheter according to an embodiment;
[0034] FIG. 6 is an illustration of a system for operating a
catheter according to an embodiment.
DESCRIPTION OF EMBODIMENTS
[0035] There is a motivation in known balloon catheters, in
particular that of WO'414, to position the guide wire lumen (OWL)
centrally within the shaft and the balloon to ease the insertion of
the catheter into a body, and simplify the manufacturing process.
Since the GWL is centrally disposed within the balloon, the cooling
element must be provided off-centre, as viewed in a plane normal to
the longitudinal axis of the cooling element. Due to the thermal
resistance of the fluid which is inside the balloon when the
balloon is inflated, areas of the surface of the balloon which are
further from the cooling tube will not be cooled as quickly or
effectively as those which are nearer the cooling tube. The surface
of the balloon and any surrounding tissue will therefore cool
unevenly.
[0036] Embodiments of the invention provide a new and advantageous
design of balloon catheter. The new design of catheter overcomes
the above problem of uneven cooling by arranging the cooling
element and the GWL inside the flexible heat transfer element, such
that, when inflated, the cooling element is substantially central
within the balloon and the GWL is parallel to and radially offset
from the cooling element. Spatial variations in heat transfer
across the balloon are hence reduced, thereby enabling improved
cryotherapy. Further still, the advantages of the cooling elements
disclosed in WO'414 may be retained.
[0037] The catheter design has a wide range of applications,
particularly in the field of coronary vascular diseases, which may
include plaque stabilisation. Of course, the size of the catheter
may be adjusted depending on the application and thus the catheter
is also in principle suitable for other applications including
atrial fibrillation, the treatment of renal denervation and tumour
ablation.
[0038] The catheter is a balloon catheter and comprises a plurality
of lumens supported inside a common shaft, except for in a balloon
region where they are instead provided within a flexible heat
transfer element. The flexible heat transfer element is configured
to be inflated to form a balloon. One or more lumens are provided
inside the shaft for providing a supply and return of inflation
fluid to the balloon, as well as the cooling element for cooling
the inflation fluid. The cooling element extends from the shaft and
is preferably unsupported within the balloon but embodiments also
include the cooling element being attached to the GWL.
[0039] The cooling element is elongate and typically substantially
cylindrical, comprising tubular walls. The cooling element also
preferably comprises first and second tubes for providing supply
and return paths of a coolant, wherein the first tube (which is
also referred to herein as the supply lumen) is provided inside a
larger second tube (which is also referred to herein as the return
lumen). The first tube and the second tube are each elongate and
extend along axes that are substantially parallel to one another.
The distal tip of the return lumen may be closed, whereas the
distal tip of the supply lumen may be open and stop short of the
end of the return lumen such that coolant may flow from the supply
lumen in a first direction into the return lumen, and then flow in
a second direction, opposite to the first direction, back along the
return lumen. When the coolant flows from the supply lumen to the
return lumen it moves into a region of increased volume and
consequently reduces in pressure. This causes a phase change in the
coolant, wherein at least some of the coolant will evaporate,
causing the temperature of the cooling element to reduce.
[0040] The one or more lumens that provide supply and return flows
of a fluid for inflating the balloon are preferably completely
separate from the lumens used to supply the coolant. The inflation
of the balloon and the cooling of the cooling element are
preferably performed by separate mechanisms and these operations
can be controlled and operated independently of each other.
[0041] The catheter may also contain a means for heating the
inflation fluid within the balloon. This could be used, for
example, if the inflation fluid froze during treatment and it was
necessary to rapidly thaw the inflation fluid. The ability to
induce such rapid thawing is particularly beneficial in case the
catheter needs to be removed from an artery quickly, for example in
emergency situations. The heat could be provided by any type of
heater, for example a small electric heater, such as a resistor,
positioned inside the balloon but outside the cooling element and
supplied by an electric current via wires running down the catheter
shaft. The heater element could be formed by a thin film resistor
printed on the outer surface of the cooling element, a discrete
resistor positioned inside the balloon, or by the inflation fluid
itself. In the case where the inflation fluid forms the heater
element, wires would supply electricity to electrodes at the
proximal and distal ends of the balloon and terminate there, in
contact with the inflation fluid, so that an AC or DC current could
be passed through the inflation fluid inside the balloon, causing
it to warm up.
[0042] In use, the catheter is inserted into a body such that the
balloon region is positioned next to a region of tissue to be
cooled in a vessel. For example, if the catheter is used instead
for plaque stabilisation by cryotherapy, the balloon region may be
positioned next to the plaque. The catheter's balloon is inflated
by a liquid and the outer surface of the balloon comes into thermal
contact with the tissue. Coolant is supplied to the cooling element
and the temperature of the cooling element reduces. The inflation
liquid within the balloon contacts the outer surface of the cooling
element and is thereby cooled. It is important to remove all gas
from the balloon prior to inflating, as gas bubbles in the balloon
will have an impact on the heat conduction through the balloon.
This is typically performed using a vacuum pump or syringe before
the catheter is inserted into the body. However it may
alternatively be performed in vivo.
[0043] An advantageous aspect of the above-described catheter
design is that the coolant of the cooling element is not the same
as the fluid used to inflate the balloon. The cooling element can
safely support a phase change of the coolant since the cooling
element is closed. Since the coolant is not in fluid communication
with the inflatable flexible heat transfer membrane, there is
little chance of it leaking from the catheter into a blood vessel
and so the requirement to have a double layered balloon may be
avoided. A single layered balloon is significantly more
maneuverable and streamlined than a balloon with multiple
membranes. Moreover, the catheter design is simpler than known
designs employing a double balloon system and this reduces costs
and manufacturing complexity.
[0044] The arrangement of the coolant supply lumen inside the
coolant return lumen allows for the cooling element to maintain a
small cross sectional area. This, in combination with the fact that
only one cooling element is required, enables the catheter (in
particular the shaft) to maintain a small diameter. This makes it
particularly suitable for applications in small diameter arteries,
such as in the coronary or smaller peripheral vasculature, where
known catheter designs are difficult to insert and/or
manoeuvre.
[0045] A further benefit of the preferred cooling element design is
that cooling due to the phase change occurs in a clearly defined
location that can be controlled as required. This improves the
efficiency of the catheter system since the lumens that deliver
coolant do not need to have high levels of insulation between the
coolant and the surrounding environment. Moreover, the parallel
arrangement of supply and return lumens means that the liquid
coolant is kept cool by the cold, gaseous coolant returning from
the distal tip of the catheter. This helps prevent the liquid
coolant from boiling as it flows into that part of the catheter
which is inside the body (and therefore at 37.degree. C.).
[0046] The cooling element and the guide wire lumen are arranged
inside the flexible heat transfer element such that, when inflated
the cooling element is substantially central within the balloon and
the guide wire lumen is parallel to and radially offset from the
cooling element. The central axis of the balloon will typically
extend through the elongate cooling element, in the direction of
the longitudinal axis of the cooling element. In embodiments where
the balloon is elongate, for example, substantially cylindrical,
the central axis of the balloon is also the major axis of the
balloon.
[0047] The longitudinal axis of the cooling element is generally
not exactly the same as the central axis of the balloon. It is
advantageous to arrange the cooling element so that the thermal
resistance between the cooling element and the surface of the
balloon is uniform in all radial directions (i.e. all directions
perpendicular to the longitudinal axis of the cooling element). In
order to compensate for the presence of the GWL (and any other
lumen that may be provided inside the balloon), this may mean that
the cooling tube is not exactly centred inside the balloon. The
cooling element is therefore only `substantially central` within
the balloon. In some embodiments the longitudinal axis of the
cooling element may be distally offset from the central axis of the
balloon by anything from 0 to 33% of the radius of the balloon,
more typically 0 to 20%. For example, for a cylindrical 3 mm
diameter balloon having a 1 mm diameter cooling element, the centre
of the cooling element may be up to 0.5 mm offset from the centre
of the balloon, as viewed in a plane normal to the longitudinal
axis of the cooling element. The exact position of the cooling
element within the balloon may vary slightly during use as the
cooling element may be free to vibrate inside the balloon. However
the arrangement of the cooling element relative to the GWL should
remain the same.
[0048] Further advantages of embodiments are set out in the
detailed description provided below.
[0049] FIG. 1 shows a cross section of the design of a cooling
element 105 of a catheter according to an embodiment. On the left
hand side of FIG. 1 are shown the tubular supply lumen 102 and the
tubular return lumen 101 of the coolant. The supply lumen 102 is
positioned inside the return lumen 101 in a substantially co-axial
configuration. An end of the supply lumen 102 is connected to, and
in fluid communication with, a restriction tube 103. The
restriction tube 103 has a narrower diameter than the supply lumen
102. The other end of the return lumen 101 to that connected to the
supply lumen 102 ends in a cylindrical cooling chamber 104 of
cooling element 105. In the present embodiment, the cooling chamber
104 has a slightly larger diameter than the return lumen 101 and
extends over the outside of the return lumen 101.
[0050] In use, a flow of pressurised coolant is input to the supply
lumen 102. The coolant may be a liquid or a mixture of a liquid and
a gaseous form of the coolant. The restriction tube 103 at the end
of the supply lumen 102 ensures that there is little pressure drop
within the supply lumen 102 and so most, or all, of the pressurised
liquid coolant remains in the liquid phase in the supply lumen 102.
Along the length of the restriction tube 103, the pressure drops
from a maximum value at the connection to the supply lumen 102 to a
lower pressure at the exit of the restriction tube 103 into the
cooling chamber 104. When the liquid coolant flows into the
restriction tube 103 the pressure drop caused by the restriction
means that the pressure of the liquid falls below its vapour
pressure at the temperature of its surroundings at that point. This
causes at least some of the liquid coolant to evaporate and undergo
a phase change into a gas. Liquid coolant that flows from the
restriction tube 103 into the cooling chamber 104 will also expand
and may evaporate within the cooling chamber 104 and/or return
lumen 101. The expansion of the coolant, and the phase change of
the coolant, has a cooling effect on the walls of the cooling
chamber 104. The coolant then flows from the cooling chamber 104,
in liquid and/or gaseous form, through the return lumen 101. The
pressure within the return lumen 101, and thereby the cooling
chamber 104, is preferably reduced by a vacuum pump. The vacuum
pump, described in more detail later, operates on the other end of
the return lumen 101 to that connected to the cooling element 105.
The reduction of pressure both increases the cooling effect due to
expansion and phase change of the coolant and ensures that the
coolant in the cooling chamber 104 flows into the return lumen
101.
[0051] FIG. 2 shows a perspective of the cooling element 105 of
FIG. 1. The cooling chamber 104 has a slightly larger diameter than
the return lumen 101. A greater cooling effect is achieved since
more coolant will undergo a phase change in the cooling chamber
104. In addition, the outer diameter of the cooling chamber 104 has
a larger surface area and is therefore more effective at cooling
the inflation fluid.
[0052] Preferably the lumens of the cooling element are made of
reasonably strong materials so that they can withstand the pressure
of a pressurised coolant. In some embodiments these lumens also
have a degree of flexibility so that the catheter can deform to
match the profile of an artery.
[0053] The supply lumen 102, return lumen 101 and restriction tube
103 may be made of nylon, tri-layered tubing, polyimide, PEBAX.TM.,
such as PEBAX 55D, or other suitable materials. The supply lumen
102 and return lumen 101 may also be metal or polymer braided to
add extra strength and flexible properties. The restriction tube
103 and supply lumen 102 may be made at the same time so that they
are integral with each other, or they may be constructed as
separate components and then glued together. Furthermore the
cooling chamber 104 may be made entirely, or in part, of copper so
that the cooling chamber 104 has good thermal conductivity
properties. Alternatively, the entirety of the cooling element 105
may be made from polyimide, as this material is strong, enabling
the walls to be made extremely thin. Using the same material
throughout the cooling element 105 also improves the ease of
manufacture of said cooling element.
[0054] Preferably, the coolant is N.sub.2O and enters the
restriction tube 103 with substantially all of the coolant being in
the liquid phase. The coolant may exit the restriction tube 103
with some of the N.sub.2O being in the liquid phase and some of the
N.sub.2O being in the gas phase. Preferably, most of the N.sub.2O
is in the liquid phase.
[0055] The embodiment shown in FIG. 3 differs from that shown in
FIG. 1 in that the cooling chamber 301 of the cooling element 302
has the same inner and outer diameters as the return lumen 101. The
cooling chamber 301 is still closed, i.e. blocked, at the other end
to that connected to the return lumen 101. The dimensions and
materials of the return lumen 101, supply lumen 102 and restriction
tube 103 may be the same as described above with reference to FIGS.
1 and 2. The length of the cooling chamber 301 from the end of the
restriction tube 103 to the closed end of the cooling chamber 301
is preferably 1 mm to 15 mm. Advantageously, the cooling chamber
301 is narrower than that shown in FIGS. 1 and 2.
[0056] The presence of a restriction tube 103 and a distinct
cooling chamber 104 is optional however. In alternative
embodiments, the liquid coolant may flow directly from the supply
lumen 102, into the return lumen 101, either through the distal tip
(i.e. end) of the supply lumen 102 or through one or more apertures
in the wall of supply lumen 102, distributed along its length. In
this case, some of the coolant may undergo a phase change when
moving to enter the return lumen 101, which has a lower pressure
than the supply lumen 102. This lower pressure may be achieved by
ensuring that the annular internal volume of the return lumen 101
is larger than the internal volume of the supply lumen 102 and/or
by using a vacuum pump.
[0057] FIG. 4 is a perspective view of a catheter 10 according to
an embodiment. The catheter 10 comprises a hollow tubular shaft 2
which extends along the length of the catheter and envelops the
lumens provided within except in a balloon region 1, where an
inflatable flexible heat transfer member 16 is provided. The shaft
2 is made of polyether block amide as braided, or unbraided,
PEBAX.TM., such as PEBAX 55D, and is formed using extrusion or a
heat reflow process.
[0058] The interior of the shaft 2 comprises a conduit 18, an
elongate, cylindrical cooling element 11 and a cylindrical guide
wire lumen (GWL) 17. The cooling element 11 may be similar to any
of the embodiments described in FIGS. 1 to 3 and comprises a supply
lumen 102 provided inside a return lumen 101.
[0059] The cooling element is provided within an inflatable heat
transfer element in the form of a membrane 16 that is configured to
be inflated into a balloon 70. The cooling element extends along
the longitudinal axis of the balloon 16 in a straight line until it
terminates near the distal end of the balloon, preferably
approximately midway along the distal half of the balloon region 1.
The cooling element 11 is centrally arranged and the flexible heat
transfer member 16 shaped such that, when the balloon 70 is
inflated, a substantially even cooling distribution is applied
across the balloon 70. In particular the cooling element 11 and the
guide wire lumen (GWL) are arranged such that the outside of the
balloon 70 (i.e. the surface of the inflatable heat transfer
membrane 16) is cooled quickly and uniformly. This is later
discussed in more detail in connection with FIG. 5.
[0060] The GWL 17 is configured to be threaded over a surgically
implanted guide wire 15 (shown in FIG. 5), when in use, for
positioning the catheter 10 inside a patient. The GWL 17 extends
from the guide wire entrance aperture at the distal tip of the
catheter 10, to a guide wire exit aperture provided on the shaft 2
(as is standard for Rapid Exchange catheters). Alternatively, an
`over the wire` configuration may be used. The GWL 17 is a hollow
tube and is made of tri-layer or a similar material.
[0061] The inflatable heat transfer membrane 16 is adhered to the
distal tip of the shaft 2 on its proximal end and the GWL 17 on its
distal end. The central region between these two ends is configured
to be inflated into a substantially elongate, and substantially
cylindrical balloon 70. Although the schematic illustration of FIG.
4 shows the membrane 16 to extend from the shaft 2 at the proximal
end of the balloon region 1 at a sharp, constant angle up towards a
cylindrical region (and back from this region towards the GWL 17 at
the distal end), it should be understood that this profile is
typically tapered, with the shape being primarily dictated by the
elasticity and shape of the flexible heat transfer membrane 16,
rather than any internal supporting members. The angle at which the
membrane 16 extends from the shaft 2 at the proximal end of the
balloon region 1 and later adjoins onto to the GWL 17 at the distal
end of the balloon region 1 varies about the longitudinal axis 60
of the cooling element 11 (and the central axis 50 of the balloon).
This ensures that the cooling element 11 is located centrally
within the balloon 70, as is evident by FIG. 4. This means that
although the central region of the balloon 70 is substantially
uniform and cylindrical, the tapered end regions are
asymmetric.
[0062] Embodiments also include the inflated balloon alternatively
being substantially spherical. A degree of asymmetry may be
introduced however in order to achieve central positioning of the
cooling element inside the balloon. The conduit 18 (referred to
herein as the inflation lumen) is provided for supplying an
inflation fluid for inflating the flexible heat transfer membrane
16 so as to form the inflated balloon 70. The inflation lumen 18
extends along the inside of the shaft 2 and, in this embodiment,
protrudes from the shaft 2 into the balloon region 1. Alternatively
however the inflation lumen may terminate at the end of the shaft
2. In some embodiments a plurality of said inflation lumens may be
provided in order to allow faster inflation or to reduce the
overall cross sectional area of the shaft 4 since in some instance
two or more small inflation lumens may be physically easier to
accommodate inside the shaft 2 than one large inflation lumen.
[0063] The shaft 2, and in particular, the space between the lumens
provided inside the shaft 2, may act as a return path for providing
a flow of inflation fluid from the balloon 70 back along the shaft
2 in a reverse direction to the flow of inflation fluid in the
inflation lumen 18. This enables space savings inside the shaft 2
since it is not necessary to provide a separate deflation tube.
Alternatively, the flow direction of the inflation fluid may be
reversed such that the conduit 18 behaves as a deflation lumen
whilst the shaft 2 behaves as an inflation lumen. Furthermore the
shaft 2 and/or inflation lumen 18 may function as both an inflation
and deflation lumen in some circumstances, in which case the
pressure is simply reversed at one end of the shaft 2 and/or
inflation lumen 18.
[0064] It is desirable to provide a shaft 2 having a small diameter
so as to allow the catheter to more readily fit through small
vessels. In an embodiment this may be achieved using a process
called `reflow` where the outer wall of the shaft 2 is extruded
around the inner lumens of the shaft 2 (comprising the inflation
lumen 18, GWL, the cooling element 11 and optionally a separate
deflation lumen), so as to form a solid body completely filling the
space between the inner lumens and the outside surface thereby
joining the inner lumens together. This composite construction
allows for a reduced thickness of the wall of the reflowed shaft
beyond what it would be if the shaft were provided in the form of a
separate tube surrounding the inner lumens. Typically this
reduction is equivalent to the thickness of the outer tube of a
shaft 5, which may be between 0.1-0.3 mm.
[0065] In an alternative embodiment the overall diameter of the
shaft 2 may be reduced by providing a cooling element 11 having an
outer surface in the form of a flattened circle, such as an oval or
an ellipse, as viewed in a plane normal to the longitudinal axis of
the cooling element 11, across the shaft 2. In this case, the
remaining lumens which extend along the inside of the shaft 2 may
be arranged around the smaller outer diameter of the cooling
element 11. This enables a shaft 2 in the form of a tube having a
smaller diameter than would otherwise be possible to be used to
tightly surround the inner lumens. The return lumen 101 of the
cooling element 11 may be formed so as to maintain its
flattened-circular shape section along its length (including the
portion protruding from the shaft 2). Alternatively the return
lumen 101 may be formed of a compliant material which deforms
inside the shaft 2 so as to form the flattened-circular inside the
shaft, whilst maintaining a circular cross-section outside of the
shaft 2.
[0066] In an embodiment, the cooling element 11 is attached to the
GWL 17 inside the balloon region 1. However, in a preferred
embodiment, the cooling element 11 is not attached to the GWL 17
inside the balloon region 1 and so the cooling chamber is free to
vibrate, i.e. move laterally with respect to the longitudinal axis
of the GWL 17.
[0067] The closed distal end of the return lumen may typically
extend approximately an additional 2.0 to 3.0 mm from the open
distal end of the supply lumen. This region could be thought of as
the cooling chamber 104.
[0068] The following dimensions may be desirable for certain
applications that may include the treatment of plaque stabilization
and atrial fibrillation on a human or animal: [0069] Cooling
element 11 [0070] Outer diameter=0.35 to 1.0 mm [0071] Outer wall
thickness=0.019 to 0.05 mm [0072] Length=15 to 30 mm [0073] Return
lumen 101 [0074] Outer diameter=0.35 to 1.0 mm [0075] Outer wall
thickness=0.019 to 0.05 mm [0076] Length=1000 to 1750 mm [0077]
Supply lumen 102 [0078] Outer diameter=0.12 to 0.4 mm [0079] Outer
wall thickness=0.014 to 0.05 mm [0080] Length=1000 to 1750 mm
[0081] Restriction tube 103 [0082] Outer diameter=0.0762 to 0.140
mm [0083] Outer wall thickness=0.019 to 0.0254 mm [0084] Length=5
to 50.8 mm [0085] Inflation lumen 18 [0086] Outer diameter=0.254 to
0.406 mm [0087] Outer wall thickness=0.0191 to 0.0508 mm [0088]
Length=1000 to 1750 mm [0089] GWL 17 [0090] Outer diameter=0.40 to
1.0 mm [0091] Inner diameter=0.35 to 0.95 mm [0092] Length=650 mm
[0093] Shaft 2 [0094] Diameter=1.35 to 3.3 mm
[0095] Embodiments also include other dimensions, in particular the
dimensions as provided in WO'414 which are incorporated herein by
reference, and the above dimensions may be scaled up or down so
that the catheter can be used with vessels of any size.
[0096] The cooling element is encompassed by the balloon 70. That
is to say, in use the cooling element 11 is within the inflation
fluid of the balloon 70 and there is no membrane of the balloon 70
arranged between the inflation fluid and the cooling element
11.
[0097] The balloon 70 is typically 15 mm to 30 mm long and, when
deflated, is preferably substantially flush with the outer surface
of the shaft 2 so that the outer diameter of the catheter is not
increased by the deflated balloon. For example, the outer diameter
of the catheter may be substantially 4 Fr (i.e. 1.333 mm). When
inflated, the outer diameter of the balloon 70 may be 2.5 mm to 4
mm. A larger balloon 70 may be required in the treatment of atrial
fibrillation however with a diameter of approximately 24 mm (e.g.
+/-10%). The dimensions of the catheter components, such as the
lumen, may be adjusted depending on the application and, in
particular, the size which the balloon is configured to be
inflated. For example, larger lumen may be desired in order to
inflate and deflate a large balloon more quickly, or apply an
increased cooling effect.
[0098] The balloon 70 may be made of a variety of materials and is
desirably compliant or semi-compliant to ensure a good fit with the
target area for effective heat exchange and a more even temperature
distribution around the tissue. The balloon 70 may also be
non-compliant if this is appropriate for the desired application.
The balloon design and construction may be as known in the art of
balloon angioplasty. However, there is no need for the balloons to
be as strong, and with as thick membranes, as those used for
angioplasty since the inflation pressures used in embodiments are
substantially lower than those used in angioplasty. This is because
the balloons are not required to enlarge the vessel. The balloons
in embodiments are only required to make a good thermal contact
with the vessel and the balloons are therefore preferably made with
a thinner membrane than balloons used for angioplasty. The balloons
can be made of a variety of materials such as silicone or
polyurethane for compliant balloons and nylon or polyester for
non-complaint balloons. Wall thickness will also vary depending on
the properties to be achieved and are generally in the range of 5
to 100 microns. The balloon may also have a substantially smooth
exterior surface so that heat transfer is optimised from the tissue
on the interior surface of the vessel. The balloon material and
thickness may be optimised to minimize thermal losses through the
balloon wall.
[0099] The balloon 70 may also be formed from a membrane 16 which
is shaped, stretched or otherwise configured such that the balloon
70 inflates anisotropically (i.e. asymmetrically) when viewed in
the plane normal to the longitudinal axis of the cooling element.
In other words, the balloon 70 may radially expand from the GWL 17
onto which it is secured by different amounts so as to ensure that
the cooling element 11 is substantially central within the balloon
70. An example of this is shown in FIG. 4 where the region A of the
balloon 70 that extends between the GWL 17 and an upper surface E
of the balloon 70 is greater than the region B which extends
between the GWL 17 and a lower surface F of the balloon 70. In the
embodiment of FIGS. 4 and 5 the range A extends 2.3 mm radially,
whereas distance B extends 0.2 mm radially, as is evident from the
scale on FIG. 5.
[0100] In use, an inflation fluid is supplied to the inflation
lumen 18 to inflate the balloon 70. The cooling element 11 is then
cooled by the expansion and/or evaporation of the coolant as
described in the above embodiments. The flow of the coolant that
may be a liquid and/or gas, from the supply lumen 102 to the return
lumen 101 (potentially via a restriction lumen and cooling chamber,
if provided) causes the distal end of the cooling element, if it is
not fixed to the GWL 17, to vibrate. Advantageously, this vibration
movement of the cooling element 105 increases the agitation of the
inflation fluid and thereby the flow over and around the cooling
chambers 104 and thereby both increases the rate at which the
inflation fluid is cooled and the temperature uniformity of the
inflation fluid. The inflation fluid is in contact with the inner
surface of the balloon 70 and the balloon 70 is thereby cooled as
the inflation fluid is cooled. The outer surface of the balloon 70
is therefore cooled due to the cooling of the inflation fluid by
the cooling element. When an operator determines that sufficient
cooling has been applied by the catheter, the balloon 70 is
deflated using the deflation lumen and the catheter can then be
removed.
[0101] The catheter could alternatively be realised with the
cooling element 11 being fixed to the GWL 17. However, this will
help maintain the relative position of the cooling element to the
balloon. The vibration of the balloon may be reduced from if the
cooling element was not fixed to the GWL, but the vibration is
preferably not entirely prevented.
[0102] Preferably the inflation fluid has a fixed volume. This
limits any damage caused by any leakage of the inflation fluid from
the catheter. Any leakage of the inflation fluid can also be
detected by monitoring the pressure of the inflation fluid when the
balloon 70 is inflated or by determining if the amount of inflation
fluid after a procedure is the same as that at the start of the
procedure.
[0103] The inflation fluid is preferably a liquid so that even if
there is a leakage from the catheter, the leakage is of a liquid
and not a gas. The inflation fluid may be a solution that comprises
sodium chloride, such as saline, with a sodium chloride
concentration of about 0.9%, or a solution with a higher
concentration of sodium chloride, preferably a 25% concentration of
sodium chloride. The inflation fluid is preferably water based, and
may include various additives to lower the freezing point.
Additives may include one or more of sodium chloride, calcium
chloride, ammonia, ethanol, propylene glycol, ethylene glycol,
propanone and butanone. Other additives may also be used, including
contrast media. The inflation fluid is also preferably sterile. To
ensure that the inflation fluid is sterile, the inflation fluid may
be provided from a separate container, such as a pre-packed bag or
syringe that is connected to the catheter.
[0104] The same apparatus for supplying the inflation fluid to into
the inflation lumen 18 may have its operation reversed so that it
is also able to deflate the balloon 70 by removing the inflation
fluid. For example the inflation fluid may be injected into the
lumen 18 by an operator pressing on the plunger of a syringe. The
same syringe can also be used to remove the inflation fluid by the
operator withdrawing the plunger. Advantageously, such an
arrangement allows an operator to easily determine if any of the
inflation fluid has leaked from the catheter by checking for
entrained air bubbles or blood in the inflation circuit following
plunger withdrawal.
[0105] FIG. 5 is a cross-sectional view of the catheter of FIG. 4
taken through the X-X' plane. The arrangement of the cooling
element 11 and the GWL 17 relative to the central (i.e.
`longitudinal` or `major`) axis 50 of the balloon 70 is
schematically illustrated. The cooling element 11 comprises a
supply lumen 102 co-axially arranged inside a return lumen 101, as
previously described. The cooling element 11 extends along its
longitudinal axis 60 in a direction parallel to the central axis 50
of the balloon 70. The longitudinal axis 60 is displaced from the
central axis 50 by a distance d in a radial direction
(perpendicular to axes 50 and 60). The cooling element 11 is still
arranged substantially centrally within the balloon 70 however,
with the central axis 50 of the balloon 70 extending through the
cooling element 11. In this case the central axis 50 extends
through the annular region between the supply lumen 101 and the
return lumen 102. In other embodiments the central axis 50 of the
balloon 70 may extend through the supply lumen 101. The
longitudinal axis 60 is typically radially offset from the central
axis 50 by less than 0.5 mm, more typically between 0.1 to 0.4
mm.
[0106] The distance of separation d between the central axis 50 of
the balloon 70 and the longitudinal axis 60 of the cooling element
11 is chosen such that, when the cooling element 11 cools the
surrounding inflation fluid, the increased thermal resistance of
the GWL 17 relative to the inflation fluid is compensated for such
that the surface of the balloon 70 is cooled uniformly (including,
the opposing edges E and F).
[0107] The GWL 17 is provided substantially off-centre with respect
to the balloon 70 such that the central axis 50 does not extend
through the GWL. The outside of the GWL 17 is typically radially
offset from the central axis 50 by at least 0.5 mm, more preferably
0.5 to 1.8 mm.
[0108] A scale is also shown in FIG. 5 to illustrate an example of
a possible arrangement in accordance with an embodiment. The scale
runs from opposing edges E and F of the balloon 70. In this
embodiment a 3 mm diameter inflated balloon 70 encases a cooling
element 11 having a 0.4 mm diameter supply lumen 102 provided
inside a 1.0 mm diameter return lumen 101. Also provided is a 0.5
mm diameter GWL 17. As shown, the return lumen 101 extends 1.3 mm
to 2.3 mm from edge E and has its longitudinal axis 60 at a
distance 1.8 mm from the edge of the balloon 70. The balloon has a
radius of 1.5 mm and so the distance d between the central axis 50
of the balloon 70 and the longitudinal axis 60 of the cooling
element 11 in this case is 0.3 mm. In other embodiments this
separation may be between 0.1 to 0.5 mm, more preferably 0.2 to 0.4
mm.
[0109] As viewed in FIG. 5, the GWL 17 extends approximately 2.3 mm
to 2.8 mm from the edge E such that it is in contact with the
outside of the cooling element 11. An inflation fluid surrounds the
outside of the cooling element 11 and the GWL 17, filling the
remaining volume shown inside the balloon 70, including in the
region 2.8 mm to 3.0 mm between the outside of the GWL 17 and the
balloon 70. In alternative embodiments the GWL 17 may be at least
partially in contact with the flexible heat transfer membrane 16
which forms the surface of the balloon 70, however preferably the
GWL 17 is not attached to the membrane 16.
[0110] FIG. 6 is an illustration of an exemplary system for using
the catheter according to the embodiments described herein to cool
a target part of a vessel. It will be understood that some of the
specifically described components may not be essential to the
operation of the system but are described for context only.
Suitable, functionally similar, or equivalent components may be
used interchangeably.
[0111] The system comprises: [0112] Coolant cylinder 1001 [0113]
Pressure regulator 1002 [0114] Tri-connector 1004 [0115] Vacuum
pump 1005 [0116] Inflation device 1003 [0117] Catheter shaft
1006
[0118] Although not shown in FIG. 6, the system also comprises a
catheter end according to any of the embodiments described
herein.
[0119] The coolant cylinder 1001 has a dip tube and spigot valve
for controlling the supply of the coolant. A flexible high pressure
hose connects the coolant cylinder to the pressure regulator 1002.
An injection tube from the pressure regulator connects to the
tri-connector 1004. Also connected to the tri-connector is an
inflation tube connected to inflation device 1003 and a vacuum tube
connected to the vacuum pump 1005. The tri-connector maintains the
injection tube, the vacuum tube and the inflation tube as separate
from each other. The tri-connector also connects to the catheter
shaft 1006 and thereby supports fluid and/or gas communication
between the catheter and the coolant supply, vacuum pump, and
inflation device.
[0120] The system may also include a heat exchanger, not shown in
FIG. 6, to cool the liquid coolant before it enters the catheter.
This will prevent boiling of the coolant as it enters the warm
environment of the patient's body. Heat may be removed from the
liquid coolant by using a refrigeration circuit or Peltier
cooler.
[0121] The system may further comprise a computer, such that the
system may be software controlled, the computer having one or more
controls and/or a user interface such as a graphical user
interface. The system may also further include assemblies for
temperature and/or pressure monitoring based on signals received
from one or more sensors.
[0122] The inflation device 1003 operates by causing an inflation
fluid to flow into the catheter shaft 1006 when the plunger is
pressed. The inflation device is also a deflation device since the
inflation fluid flows back into the device from the catheter when
the plunger is withdrawn. The inflation device may alternatively be
an electric pump.
[0123] The vacuum pump 1005, that may be an electric vacuum pump,
operates on the return lumens of the coolant. The vacuum pump 1005
advantageously lowers the pressure in the return lumen and/or
cooling chamber of the cooling elements to thereby increase the
amount of phase change of the coolant that occurs. The vacuum pump
1005 also ensures that the coolant in the supply lumens and cooling
chambers (where provided) flows into the return lumen.
[0124] A further advantage applying the vacuum pump 1005 to the
return lumens is that the pressure in the return lumen is
relatively low and less than typical blood pressure in a body. In
use, should the return lumens leak, this would result in blood
flowing into the return lumens rather than the coolant flowing out.
The vacuum pump 1005 thereby improves the safety of the
catheter.
[0125] The system may also comprise a deflation device, separate
from the inflation device 1003, that is in fluid communication with
the catheter shaft 1006 through an additional separate connection
to the tri-connector. The deflation device may be a vacuum pump,
such as an electric vacuum pump.
[0126] Variables that influence the operation of the catheter are
the pressure of the inflated balloon and the temperature of the
outer surface of the balloon. Both of these are controllable by how
the system of FIG. 6 is operated. The pressure of the balloon is
controllable by controlling the amount, and pressure of, the
inflation fluid by inflation device 1003. The temperature of the
outer surface of the balloon is dependent on both the temperature
of the cooling element, and how long the cooling element has been
cooling the inflation fluid. The temperature of the cooling element
is controllable by controlling the pressure and the amount of
coolant that flows into the catheter. The length of time that the
inflation fluid is cooled by the cooling element is easily
controlled by when the system operator starts and stops the flow of
the coolant into the catheter.
[0127] Preferably, the pressure of the balloon is maintained at
lower than 5 ATM (507 kPa), typically between 3.5 ATM (355 kPa) to
4.5 ATM (456 kPA), but may be as low as 3 ATM (304 kPa) or 1 ATM
(101 kPa). It may be desirable for the balloon pressure to be as
low as possible for effective treatment in order to mitigate the
risk of a reaction occurring in the blood vessel that leads to
re-stenosis or blockage. A short-term response to the application
of high-pressure cryotherapy is also often smooth muscle cell
proliferation, which is potentially dangerous. The tissue interface
temperature is preferably maintained within a desired range in
order to remove heat from the plaque and vessel without
significantly ablating the cells. It is noted that throughout the
present document, all pressures given as gauge pressures, that is,
above atmospheric pressure.
[0128] The temperature of the outer surface of the balloon is
maintained within appropriate ranges given the application. For
example, for cryotherapy, the temperature is preferably maintained
between +15.degree. C. (288K) and -35.degree. C. (238K) and more
preferably between 0 to -30.degree. C. (273K to 243K). For atrial
fibrillation (and other applications where tissue ablation is
required) the temperature may be much lower, for example between
-50.degree. C. to -90.degree. C. (223K to 183K), although typically
around -80.degree. C. (193K).
[0129] The exact temperature will depend on the treatment
application, according to standard practice. Depending on the type
of balloon and the heat load, there may be a temperature difference
of about 10.degree. C. to 40.degree. C. between inner and outer
balloon temperature and this can be compensated for when
controlling the system.
[0130] Preferably, sensors are provided within, on or near the
catheter end, such as on or just inside the balloon, in order to
monitor and thereby control the temperatures and pressures in a
feedback control system. For example, a thermocouple may be fixed
to the GWL or coolant return tube to measure the temperature inside
the balloon. One or more further thermocouples may be attached to
the internal or external surface of the balloon in order to measure
the balloon tissue interface temperature. In addition, a pressure
sensor may be placed inside the balloon to accurately monitor and
thereby control the pressure within the balloon. The pressure
sensor may be an open hydraulic tube with no flow, or may be
positioned on the inflation circuit near the inflator, so that the
fluid pressure inside the tube is measured outside the catheter.
The pressure sensor may also be a piezoelectric transducer,
fibre-optic transducer or other type of sensor. Pressure sensors
and a flow meter may also be positioned in the coolant circuit, to
measure the pressure and flow of the coolant.
[0131] Both temperature and pressure signals can be used to control
refrigerant flow such that balloon pressure and/or surface
temperature remain within the desired ranges. The pressure
transducer may also be used to detect any leaks within the catheter
by sensing abnormal pressures. The temperature sensor(s) may also
be used to detect vessel occlusion by the balloon.
[0132] As described earlier, the catheter may also comprise means
for heating the inflation fluid, or solidified inflation fluid,
within the balloon. Advantageously, this allows frozen inflation
fluid to be thawed quickly if required.
[0133] In order to support the sensors, means for heating and any
other devices at the distal end of the catheter, the system may
further comprise connectors to one or more power supplies, data
interfaces, or other signal processing units, configured to provide
a power supply, control signals and to convert sensor signals into
data. Electrical wires may be housed in the catheter shaft together
with the lumens or along the outside of the catheter shaft.
[0134] Preferably, the volume of the inflation fluid is fixed and
small. This minimises the damage caused by any leakage. The
injection of the inflation fluid to inflate the balloon may be
automatically controlled and performed, for example, by an operator
pressing a button. Alternatively, the inflation fluid may be
injected manually.
[0135] According to known techniques, one or more portions of the
catheter may be radiopaque and/or include a radiopaque marker. This
aids the operator of the catheter.
[0136] The cooling elements are typically characterised by supply
lumen provided inside a return lumen. The supply lumen may be
positioned centrally within the return lumen but this is not
essential. The supply lumen may alternatively lie along a side of
the return lumen or be in no way fixed to the return lumen so that
its position within the return lumen can change.
[0137] Further embodiments of the invention include those in which
the elongate cooling element is also the guide wire lumen. For
example, the cooling element itself may be configured to receive a
guide wire such that a separate guide wire lumen is not required.
In embodiments wherein the cooling element comprises a return lumen
provided inside a supply lumen, either the supply or the return
lumen may be arranged to receive a guide wire. This provides the
advantage of simplifying the design, thereby enabling the overall
size of the shaft to be reduced, as well as offering more
structural support.
[0138] Further embodiments include a number of modifications and
variations that can be made to the embodiments as described above.
In particular, all of the dimensions provided in the figures are
approximate and embodiments include catheter designs with different
dimensions. Furthermore the dimensions may also vary depending on
the size of the human or animal that is being treated. Throughout
the present document various features are described as lumens and
tubes. These terms may be used interchangeably and said features
may also be referred to as conduits.
[0139] In the above described embodiments the cooling element is
preferably substantially straight and co-linear with the abutting
end of the shaft. The cooling element may be rigid and
non-flexible. However, the cooling element is preferably flexible
so that it can bend, as is appropriate if the balloon is positioned
in a curved section of artery.
[0140] In the above-described operation of the system, operational
temperatures and pressures are provided. However, embodiments are
in no way limited to these operational temperatures and pressures.
Moreover, the operational temperatures and pressures may be varied
depending on the application. In particular, embodiments include
the catheter, and the system supporting the catheter, being
operated according to the disclosure in WO 2012/140439 A1, the
entire contents of which are incorporated herein by reference.
[0141] The balloons according to embodiments may have a thinner
membrane than balloons used for angioplasty. However, embodiments
also include using balloons with the same thickness as those used
in angioplasty so that the balloons advantageously act as a
secondary barrier in case of a leak in the cooling tube.
[0142] Other embodiments of the invention will be apparent to those
skilled in the art from consideration of the specification and
practice of the embodiments disclosed herein. It is intended that
the specification and examples be considered as exemplary only,
with a true scope and spirit of the invention being indicated by
the following claims.
* * * * *